Clin Chem Lab Med. 2026 Aug 28. doi: 10.1515/cclm-2026-1235. Online ahead of print. ABSTRACT Clostebol is an anabolic androgenic steroid prohibited at all times (class S1.1) by the World Anti-Doping Agency. In several countries, however, clostebol acetate is available without prescription in topical medicinal products, particularly Trofodermin®, creating a substantial risk of inadvertent exposure. Experimental … Read more
Clin Chem Lab Med. 2026 Aug 27. doi: 10.1515/cclm-2026-1271. Online ahead of print. ABSTRACT OBJECTIVES: To develop and apply an operational framework integrating metrological, analytical, clinical and risk evidence to authorise an output-specific reporting rule after a change in measurement procedure. METHODS: Four measurement procedure changes were evaluated: alanine aminotransferase (ALT) procedures with and without … Read more
Clin Chem Lab Med. 2026 Aug 26. doi: 10.1515/cclm-2026-1075. Online ahead of print. ABSTRACT INTRODUCTION: Hepatitis B virus (HBV) infection remains a major global public health problem. Dried blood spot (DBS) sampling is simple to collect, stable during transport, and easy to store, and may therefore provide an alternative sampling strategy for decentralized HBV testing. … Read more
Clin Chem Lab Med. 2026 Aug 24. doi: 10.1515/cclm-2026-1215. Online ahead of print. ABSTRACT Albumin measurements in serum have important diagnostic and prognostic roles. However, non-standardized measurement procedures are still used in medical laboratories. An agreed approach for the implementation of metrological traceability to the International System of Units (SI) of serum albumin measurements is … Read more
Clin Chem Lab Med. 2026 Aug 24. doi: 10.1515/cclm-2026-1125. Online ahead of print. ABSTRACT Hospital-acquired anemia is highly prevalent and largely preventable complication of hospitalization, affecting up to 40-74 % of patients and up to 90 % of intensive care units patients. Excessive diagnostic blood loss from routine phlebotomy represents a significant and modifiable contributor, … Read more
Clin Chem Lab Med. 2026 Aug 21. doi: 10.1515/cclm-2026-0944. Online ahead of print. ABSTRACT OBJECTIVES: Serum neurofilament light chain (sNfL) reflects neuroaxonal injury in relapsing-remitting multiple sclerosis (RRMS), but its clinical utility is limited by high interindividual variability and confounders such as renal function. Population-based thresholds may therefore be suboptimal for longitudinal monitoring. The reference … Read more
Clin Chem Lab Med. 2026 Aug 21. doi: 10.1515/cclm-2026-0783. Online ahead of print. ABSTRACT OBJECTIVES: Thalassemia and hemoglobinopathies are significant genetic disorders in Thailand. Routine diagnostic methods including complete blood count (CBC), hemoglobin (Hb) analysis, and targeted PCR, are effective for detecting common mutations but limited sensitivity for rare and unstable variants, and complex genotypes. … Read more
Clin Chem Lab Med. 2026 Aug 21. doi: 10.1515/cclm-2026-0870. Online ahead of print. ABSTRACT OBJECTIVES: Antiphospholipid antibodies (aPL) are essential biomarkers for classification, diagnosis, and risk stratification of antiphospholipid syndrome (APS). Although automated analytical platforms, such as chemiluminescent immunoassay (CLIA), and particle-based multi-analyte technology (PMAT), are increasingly implemented in routine laboratories, uncertainty remains regarding their … Read more
Clin Chem Lab Med. 2026 Aug 21. doi: 10.1515/cclm-2026-0836. Online ahead of print. ABSTRACT OBJECTIVES: Preanalytical errors account for approximately 60-70 % of all laboratory errors, with sample misidentification among the most frequent causes of inaccurate and unreliable test results. Pre-barcoded tubes (PBTs) are collection tubes uniquely identified during manufacturing with machine-readable labels, eliminating the … Read more
Clin Chem Lab Med. 2026 Aug 19. doi: 10.1515/cclm-2026-0593. Online ahead of print. ABSTRACT OBJECTIVES: Therapeutic drug monitoring (TDM) of gentamicin is critical to ensure efficacy and minimize toxicity. We report a candidate reference measurement procedure (RMP) to quantify gentamicin in biological matrices, establishing an unbroken traceability chain to the International System of Units (SI). … Read more
Clin Chem Lab Med. 2026 Aug 18. doi: 10.1515/cclm-2026-1024. Online ahead of print. ABSTRACT The main purpose of establishing APS is to ensure that test performance aligns with their specific clinical goals. Analytical performance specifications serve multiple functions: as acceptance criteria to verify that in vitro diagnostic medical devices (IVD MD) meet regulatory and quality … Read more
Clin Chem Lab Med. 2026 Aug 17. doi: 10.1515/cclm-2026-0410. Online ahead of print. ABSTRACT OBJECTIVES: 24 hour urine free cortisol measurement is widely used for screening Cushing’s syndrome, but its reliability is limited by variability due to inherent biological variation and variation introduced by collection errors. This study aimed to determine the proportion of inaccurately … Read more
Clin Chem Lab Med. 2026 Aug 17. doi: 10.1515/cclm-2026-0950. Online ahead of print. ABSTRACT Lipoprotein X (LpX) is an abnormal lipoprotein-like particle occurring mainly in cholestasis, lecithin-cholesterol acyltransferase deficiency, post-transplant cholestatic liver dysfunction, hepatic graft-versus-host disease, and selected intravenous lipid emulsion or parenteral nutrition settings. Enrichment in phospholipids and unesterified cholesterol, paucity of cholesteryl esters … Read more
Clin Chem Lab Med. 2026 Aug 12. doi: 10.1515/cclm-2026-0509. Online ahead of print. ABSTRACT OBJECTIVES: Vancomycin is a glycopeptide antibiotic used to treat severe Gram-positive infections; its narrow therapeutic window makes therapeutic drug monitoring (TDM) critical. We report the development of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) candidate reference measurement procedure (RMP) to quantify vancomycin … Read more
Clin Chem Lab Med. 2026 Aug 11. doi: 10.1515/cclm-2026-0844. Online ahead of print. ABSTRACT OBJECTIVES: Serum M-protein analysis is central to the assessment of monoclonal gammopathies. Quantitation and isotyping are commonly performed by SPE or CZE and IFE or IT, respectively. While these assays are widely used, they are characterized by limited sensitivity and subjective … Read more
Clin Chem Lab Med. 2026 Aug 11. doi: 10.1515/cclm-2026-0777. Online ahead of print. ABSTRACT OBJECTIVES: Therapeutic monoclonal antibodies (t-mAbs) are increasingly used in oncology, hematology, autoimmune diseases, and inflammatory disorders. Because most of these agents are monoclonal immunoglobulins, they may be detected by serum immunofixation electrophoresis (IFE) and mimic pathological monoclonal proteins. METHODS: We analyzed … Read more
Clin Chem Lab Med. 2026 Aug 7. doi: 10.1515/cclm-2026-0941. Online ahead of print. ABSTRACT OBJECTIVES: Bone status indices (BSIs) are increasingly used in metabolic bone disease, yet global laboratory practices remain poorly characterized. Building on recent IOF-IFCC nomenclature and ESCEO-IOF-IFCC recommendations, we conducted an international descriptive survey of BSI practices. METHODS: A cross-sectional web-based questionnaire … Read more
Clin Chem Lab Med. 2026 Aug 7. doi: 10.1515/cclm-2026-0817. Online ahead of print. ABSTRACT OBJECTIVES: Clinical laboratories face growing demands to balance healthcare needs with cost and resource efficiency. Solutions that optimise space, cut costs, and minimise water use and waste offer a competitive edge. This study compares water consumption, waste generation, and reagent efficiency … Read more
Clin Chem Lab Med. 2026 Aug 7. doi: 10.1515/cclm-2026-0949. Online ahead of print. ABSTRACT Integrated diagnostics is an emerging multidisciplinary model of care that integrates traditionally siloed domains, including pathology, radiology, genomics, and laboratory medicine, into a coordinated framework designed to improve diagnostic accuracy, treatment selection, and clinical outcomes. In this position statement, the EFLM … Read more
Clin Chem Lab Med. 2026 Aug 6. doi: 10.1515/cclm-2026-0428. Online ahead of print. ABSTRACT OBJECTIVES: Therapeutic drug monitoring (TDM) of meropenem is critical for optimizing clinical efficacy and minimizing toxicity. We describe the validation of an isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) candidate reference measurement procedure (RMP) for the quantification of meropenem in human serum … Read more
Clin Chem Lab Med. 2026 Aug 4. doi: 10.1515/cclm-2026-0711. Online ahead of print. ABSTRACT OBJECTIVES: Limited guidance on the use and interpretation of cardiac troponin (cTn) testing in pediatric populations has restricted its broader adoption, despite the significant burden of congenital and acquired cardiac conditions in children. This survey aimed to evaluate global availability, utilization … Read more
Clin Chem Lab Med. 2026 Aug 3. doi: 10.1515/cclm-2026-0609. Online ahead of print. ABSTRACT OBJECTIVES: Pregnancy involves dynamic metabolic changes that cannot be accurately interpreted using population reference intervals (RI). The aim was to develop continuous reference curves for common hematology and biochemistry laboratory analytes in pregnancy and to assess their agreement with the RIs … Read more
Clin Chem Lab Med. 2026 Jul 30. doi: 10.1515/cclm-2026-0536. Online ahead of print. ABSTRACT Population screening for type 1 diabetes (T1D) using pancreatic islet autoantibodies is increasingly recognized as a promising strategy to reduce diabetic ketoacidosis and identify individuals during the presymptomatic stages of the disease. In Italy, Law 130/2023 and the implementing decree of … Read more
Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0875. Online ahead of print. ABSTRACT BACKGROUND: Patient risk management has become central to clinical laboratory quality standards, including the Clinical and Laboratory Standards Institute (CLSI) EP23 2nd edition (CLSI EP23-ED2), International Organization for Standardization (ISO) 15189:2022, ISO 22367:2026, and ISO 14971:2019. A key component of risk … Read more
Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0469. Online ahead of print. ABSTRACT OBJECTIVES: Traditional urine immunofixation electrophoresis (uIFE) is cumbersome, has limited sensitivity, and is subjectively interpreted. This is especially problematic in renal impairment where accumulation of polyclonal free light chains may pseudonormalize the serum free light chain (sFLC) ratio, compromising its reliability … Read more
Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0815. Online ahead of print. ABSTRACT OBJECTIVES: External quality assessment (EQA) is essential for ensuring reliable biochemical genetic testing. This study evaluated long-term performance trends in ERNDIM quantitative EQA schemes, including special assays in serum (SAS), special assays in urine (SAU), purines and pyrimidines in urine (PPU), … Read more
Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0185. Online ahead of print. ABSTRACT OBJECTIVES: Colorectal cancer (CRC) screening is crucial for early detection, yet the invasiveness of the gold-standard colonoscopy limits compliance. To address the limitation, this study proposes a novel multi-target free DNA methylation model and evaluated its risk stratification performance for CRC … Read more
Clin Chem Lab Med. 2026 Jul 28. doi: 10.1515/cclm-2026-0570. Online ahead of print. ABSTRACT OBJECTIVES: Cardiovascular disease (CVD) is a leading cause of mortality worldwide. Emerging lung cancer screening in smokers may offer an opportunity for simultaneous cardiovascular risk evaluation. We developed a mobile CT screening unit and assessed the feasibility of integrating dyslipidemia screening … Read more
Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0864. Online ahead of print. ABSTRACT INTRODUCTION: To analyse the structural and operational divergences between NF EN ISO 15189:2022 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in the context of medical laboratory practice in Europe. CONTENT: This article provides a structured comparative analysis … Read more
Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0790. Online ahead of print. ABSTRACT OBJECTIVES: Understanding whether the novel long-T ITC complex might assist in interpreting clinical prognostic utility compared to established cardiac biomarkers is needed. We determined long term major adverse cardiac events (MACE) and all-cause mortality (ACM) predicated on novel long-T ITC complex … Read more
Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0863. Online ahead of print. ABSTRACT OBJECTIVES: Biological variation (BV) data are essential for many purposes in laboratory medicine, however, the complex statistical analysis remains a barrier for delivery of BV data. This study describes the development of a web-based BV Calculator based on the Biological Variation … Read more
Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0627. Online ahead of print. ABSTRACT OBJECTIVES: Accurate interpretation of pediatric laboratory test results requires robust age- and sex-specific reference intervals (RIs). Undertaking studies to establish RIs across the pediatric age range is particularly challenging due to rapid physiological changes during growth and development. While the Roche … Read more
Clin Chem Lab Med. 2026 Jul 27. doi: 10.1515/cclm-2026-0903. Online ahead of print. ABSTRACT Laboratory medicine is undergoing a profound transformation driven by advances in artificial intelligence (AI), automation, and data interoperability. By 2050, laboratories may evolve from analytical testing facilities into an interconnected health intelligence capable of translating biological, digital, and environmental data into … Read more
Clin Chem Lab Med. 2026 Jul 23. doi: 10.1515/cclm-2026-0704. Online ahead of print. ABSTRACT OBJECTIVES: Most available data on human chorionic gonadotropin (hCG) elevations in menopausal women are derived from studies using Roche assays, with limited evidence across other immunoassay platforms. This study aimed to establish assay-specific reference values for hCG and evaluate the impact … Read more
Clin Chem Lab Med. 2026 Jul 23. doi: 10.1515/cclm-2026-0866. Online ahead of print. ABSTRACT OBJECTIVES: Urinalysis is essential for detecting kidney disease, urinary tract infections, and diabetes mellitus. Point-of-care testing enables rapid screening in decentralized settings and supports low-throughput laboratories. This study evaluated the Sysmex UC-1000 according to the 2023 EFLM urinalysis guidelines in a … Read more
Clin Chem Lab Med. 2026 Jul 21. doi: 10.1515/cclm-2026-0358. Online ahead of print. ABSTRACT OBJECTIVES: Launched in 2012, the Choosing Wisely initiative promotes evidence-based recommendations to reduce unnecessary tests and treatments. This study reviewed laboratory-related recommendations from five countries (USA, UK, Germany, Switzerland, and Austria) to assess their scientific validity. METHODS: Choosing Wisely websites were … Read more
Clin Chem Lab Med. 2026 Jul 21. doi: 10.1515/cclm-2026-0380. Online ahead of print. ABSTRACT INTRODUCTION: The identification of early biomarkers is a critical prerequisite for the development and optimization of preventive strategies targeting preterm prelabour rupture of membranes (pPROM). The aim of this systematic review was to evaluate first trimester serum biomarkers for predicting the … Read more
Clin Chem Lab Med. 2026 Jul 17. doi: 10.1515/cclm-2026-0201. Online ahead of print. ABSTRACT OBJECTIVES: Practical implementation of patient-based real-time quality control (PBRTQC) requires analyte- and institution-specific optimization. This study evaluated the operational feasibility of average-of-normals (AoN)-based PBRTQC through a structured selection process and prospective event-based validation. METHODS: PBRTQC monitoring was performed using the Average … Read more
Clin Chem Lab Med. 2026 Jul 16. doi: 10.1515/cclm-2026-0511. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to establish a comprehensive panel of dried blood spot (DBS)-specific reference intervals (RIs) for vitamins, essential elements, and potentially toxic elements (PTEs) in Chinese adults, and to introduce a hierarchical decision framework for selecting between healthy- and … Read more
Clin Chem Lab Med. 2026 Jul 15. doi: 10.1515/cclm-2026-0671. Online ahead of print. ABSTRACT OBJECTIVES: Capillary blood sampling enables minimally invasive testing and decentralized workflows, but interchangeability with venous specimens may depend on collection site, device, and matrix. METHODS: We conducted a single-center, paired clinical study of 480 adults yielding 960 capillary specimens (fingertip lancet … Read more
Clin Chem Lab Med. 2026 Jul 14. doi: 10.1515/cclm-2026-0684. Online ahead of print. ABSTRACT OBJECTIVES: Peritonitis is a feared complication to peritoneal dialysis (PD), requiring empirical broad-spectrum antibiotics. A rapid method to predict culture positivity and bacterial Gram classification could enable earlier targeted therapy and reduce unnecessary antibiotic exposure. This study evaluated the diagnostic performance … Read more
Clin Chem Lab Med. 2026 Jul 14. doi: 10.1515/cclm-2026-0463. Online ahead of print. ABSTRACT OBJECTIVES: Schistocyte quantification is essential for diagnosing microangiopathic hemolytic anemia (MAHA) and thrombotic microangiopathies (TMA). Early exclusion is critical for guiding appropriate management. However, the reference standard remains time-consuming manual microscopy, highly operator-dependent. In this study, the CellaVision Advanced RBC Application … Read more
Clin Chem Lab Med. 2026 Jul 13. doi: 10.1515/cclm-2026-0647. Online ahead of print. ABSTRACT OBJECTIVES: Inductively coupled plasma-mass spectrometry (ICP-MS) is a gold standard for testing trace elements. Despite its wide adoption in clinical laboratories, sample preparation workflows are typically manual and prone to environmental contamination. The objective of this study was to develop an … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0108. Online ahead of print. ABSTRACT OBJECTIVES: Quantitation of plasma vitamins A and E is essential for assessing nutritional status. Traditional methods typically involve liquid-liquid extraction followed by high-performance liquid chromatography with UV detection (HPLC-UV). In this study, we evaluated an automated sample extraction-method paired with liquid … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0938. Online ahead of print. ABSTRACT OBJECTIVES: Approximately 30 % of laboratory tests are ordered inappropriately, substantially impacting patient care, costs, and carbon footprint of laboratories. Predefined laboratory test panels are a pragmatic and routinely used tool in laboratories, where tests are bundled for efficiency to diagnose … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0643. Online ahead of print. ABSTRACT The 2015 Milan consensus proposed three models for analytical performance (APS) specifications for laboratory tests. Model 1 recommends defining analytical performance specifications based on impact on clinical outcomes. We undertook a targeted literature review to identify and evaluate studies using indirect … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0977. Online ahead of print. ABSTRACT This collective opinion paper, based on presentations delivered during the two-day European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Strategic Conference 2026, “Laboratory Medicine for Society” (Prague, Czech Republic, 24-25 April 2026) offers a forward-looking overview of the Federation’s strategic … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0408. Online ahead of print. ABSTRACT OBJECTIVES: Point-of-care (POC) International Normalised Ratio (INR) testing provides rapid anticoagulation monitoring. Still, it is susceptible to systematic bias, particularly at supratherapeutic levels, which can lead to inappropriate warfarin dose adjustments and increased thrombotic risk. This study evaluated bias trends between … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2025-0872. Online ahead of print. ABSTRACT OBJECTIVES: Calibration is a cornerstone of clinical chemistry test results and maintaining an in-house LDT requires periodic renewal of calibrators. Here we present the introduction of a new set of native human serum calibrators, using different curve fitting approaches for long-term … Read more
Clin Chem Lab Med. 2026 Jul 10. doi: 10.1515/cclm-2026-0489. Online ahead of print. ABSTRACT OBJECTIVES: In polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome, when monoclonal plasma cell proliferation is absent, it is considered ‘non-secretory POEMS syndrome’. We aimed to study whether M-protein was detectable by mass spectrometry (MS) in previously non-secretory POEMS syndrome. … Read more
Clin Chem Lab Med. 2026 Jul 9. doi: 10.1515/cclm-2026-0444. Online ahead of print. ABSTRACT A widely accepted approach to setting Analytical Performance Specifications (APS) in laboratory medicine is the Milan models. The Milan Model 1b is an approach in which APS are developed based on patient classification or clinical decision-making, noting that these factors are … Read more
Clin Chem Lab Med. 2026 Jul 9. doi: 10.1515/cclm-2026-0626. Online ahead of print. ABSTRACT OBJECTIVES: Identification of acute kidney injury (AKI) in neonatology and paediatrics continues to present challenges to laboratories. Emerging biomarkers are being developed which may offer early detection but haven’t been adopted in current guidelines yet. The aim of this IFCC survey … Read more
Clin Chem Lab Med. 2026 Jul 9. doi: 10.1515/cclm-2025-1488. Online ahead of print. ABSTRACT OBJECTIVES: Invasive prenatal diagnosis is recommended for high-risk pregnancies, but many decline due to potential complications. To date, no non-invasive prenatal testing (NIPT) simultaneously detects monogenic diseases, balanced chromosomal rearrangements (BCRs), and aneuploidies. We developed a comprehensive NIPT to detect monogenic … Read more
Clin Chem Lab Med. 2026 Jul 7. doi: 10.1515/cclm-2026-0957. Online ahead of print. ABSTRACT OBJECTIVES: Red blood cell (RBC) morphology in peripheral blood smears (PBS) remains essential for the differential diagnosis of anemia and other hematologic disorders. As yet unclassified poikilocytes, fish-shaped RBCs and pincer (mushroom-shaped) cells are rarely observed but have been described as … Read more
Clin Chem Lab Med. 2026 Jul 6. doi: 10.1515/cclm-2026-0789. Online ahead of print. ABSTRACT Clinical laboratory medicine faces converging structural pressures: workforce shortages, growing data complexity, and rapid advances in artificial intelligence (AI). Some prominent developers, including Demis Hassabis of Google DeepMind, have projected the arrival of artificial general intelligence (AGI) around 2030; such timelines … Read more
Clin Chem Lab Med. 2026 Jul 6. doi: 10.1515/cclm-2026-0743. Online ahead of print. ABSTRACT OBJECTIVES: Unified Code for Units of Measure (UCUM) encodes syntax without prescribing which unit should be used. The Nomenclature for Properties and Units (NPU) terminology, developed by IFCC and IUPAC, specifies both the kind-of-quantity (e.g., mass concentration or substance concentration) and … Read more
Clin Chem Lab Med. 2026 Jul 6. doi: 10.1515/cclm-2026-0661. Online ahead of print. ABSTRACT OBJECTIVES: The objective of this study is to evaluate the ethical dimensions of reflex and reflective testing (RRT) within the framework of value-based laboratory medicine and in alignment with ISO 15189:2022. The study aims to highlight the challenges in guiding and … Read more
Clin Chem Lab Med. 2026 Jul 2. doi: 10.1515/cclm-2026-0123. Online ahead of print. ABSTRACT Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), remains a global public health challenge. Rapid and accurate diagnostic methods are critical for effective TB control. In recent years, serological diagnosis has attracted growing attention with the continuous identification of novel biomarkers, owing … Read more
Clin Chem Lab Med. 2026 Jul 2. doi: 10.1515/cclm-2026-0173. Online ahead of print. ABSTRACT OBJECTIVES: Reliable biomarkers may allow early risk stratification for mortality in older adults. Post-translational modification-derived products (PTMDPs), such as homocitrulline, and the tissue accumulation of advanced glycation end products (AGEs), measured by skin autofluorescence, have been suggested as potential biomarkers of … Read more
Clin Chem Lab Med. 2026 Jul 1. doi: 10.1515/cclm-2026-0785. Online ahead of print. ABSTRACT OBJECTIVES: To evaluate how alternative age-partitioning strategies affect result classification using discrete pediatric ferritin reference intervals (RIs). METHODS: In a prospective cohort of 3,322 apparently healthy individuals aged birth to <19 years, serum ferritin was measured on the Cobas Pro platform. … Read more
Clin Chem Lab Med. 2026 Jul 1. doi: 10.1515/cclm-2026-0504. Online ahead of print. ABSTRACT OBJECTIVES: This study aimed to present the results of translating the LOINC standard into Polish, summarize key methodological lessons, and outline the current stage of LOINC implementation in Poland. METHODS: Three editions of the LOINC dictionary translation process were conducted using … Read more
Clin Chem Lab Med. 2026 Jul 1. doi: 10.1515/cclm-2026-0934. Online ahead of print. ABSTRACT Harmonization initiatives in laboratory medicine have a long history. Nevertheless, despite substantial efforts by international federations, scientific societies, and expert working groups, their implementation and widespread adoption remain incomplete, with many initiatives still at a relatively early stage of development. More … Read more
Clin Chem Lab Med. 2026 Jun 30. doi: 10.1515/cclm-2026-0034. Online ahead of print. ABSTRACT OBJECTIVES: Albuminuria is a key biomarker of kidney damage, yet preanalytical challenges with conventional liquid urine testing, limiting its utility for decentralized and large-scale screening. This study evaluated the analytical performance of a novel dried urine spot (DUS) device, for measuring … Read more
Clin Chem Lab Med. 2026 Jun 26. doi: 10.1515/cclm-2026-0346. Online ahead of print. ABSTRACT OBJECTIVES: Carbohydrate-deficient transferrin (CDT) is a specific biomarker for chronic excessive alcohol consumption. The IFCC Working Group on CDT Standardization recommends 2-sialo-transferrin (2-sialo-Tf) as the sole measurand, with a decision threshold of 2.0 % CDTIFCC using HPLC. This study evaluates the … Read more
Clin Chem Lab Med. 2026 Jun 26. doi: 10.1515/cclm-2026-0464. Online ahead of print. ABSTRACT OBJECTIVES: Accurate estimation of glomerular filtration rate (eGFR) is necessary for early detection and staging of chronic kidney disease (CKD), risk stratification, and guiding therapies that prevent complications and progression to advanced CKD. This study aimed to evaluate the performance of … Read more
Clin Chem Lab Med. 2026 Jun 26. doi: 10.1515/cclm-2026-0579. Online ahead of print. ABSTRACT OBJECTIVES: The high variability in screening and confirmatory cut-off values for primary aldosteronism (PA) largely reflects the insufficient standardization of current analytical methods. Competitive and sandwich immunoassays show variable correlation with the reference liquid chromatography-tandem mass spectrometry (LC-MS/MS) technique. This prospective … Read more
Clin Chem Lab Med. 2026 Jun 25. doi: 10.1515/cclm-2026-0757. Online ahead of print. ABSTRACT OBJECTIVES: Advanced medullary thyroid carcinoma (MTC) is commonly monitored using calcitonin (CT) and carcinoembryonic antigen (CEA) kinetics. Pro-gastrin-releasing peptide (ProGRP) and carbohydrate antigen 19-9 (CA 19.9) have emerged as potential complementary markers, but their longitudinal prognostic value remains unclear. METHODS: This … Read more
Clin Chem Lab Med. 2026 Jun 24. doi: 10.1515/cclm-2026-0259. Online ahead of print. ABSTRACT BACKGROUND: External quality assurance (EQA) programs must assess whether the analytical performance of commonly used in vitro diagnostic (IVD) devices is fit for their intended clinical use. We developed a method for this assessment based on reclassification of results at clinical … Read more
Clin Chem Lab Med. 2026 Jun 24. doi: 10.1515/cclm-2026-0658. Online ahead of print. ABSTRACT BACKGROUND: Prompt diagnosis and treatment of vitamin B12 deficiency prevents haematological, neurological, psychological and psychiatric disturbances. During November 2024, reference interval data used for the clinical interpretation of total B12 assays was collated from participants of the UK NEQAS for Haematinic … Read more
Clin Chem Lab Med. 2026 May 20. doi: 10.1515/cclm-2026-0553. Online ahead of print. ABSTRACT OBJECTIVES: Hereditary transthyretin amyloidosis (ATTRv) is a rare autosomal dominant disorder caused by pathogenic variants in the TTR gene, with marked clinical heterogeneity and frequent underdiagnosis. Genetic confirmation is essential for patient management but is traditionally based on Sanger sequencing or … Read more
Clin Chem Lab Med. 2026 May 19. doi: 10.1515/cclm-2026-0382. Online ahead of print. ABSTRACT OBJECTIVES: The 20- and 22-kDa isoforms of growth hormone 1 (GH1) play potentially distinct physiological and pathological roles, but their structural similarity makes quantification challenging. Conventional immunoassays lack sufficient specificity, highlighting the need for more precise analytical methods. METHODS: We developed … Read more
Clin Chem Lab Med. 2026 May 19. doi: 10.1515/cclm-2026-0276. Online ahead of print. ABSTRACT OBJECTIVES: A major objective of the IFCC Committee for Education in the Use of Biomarkers in Diabetes is to monitor the success of global standardization of HbA1c through benchmark evaluation of the performance by country and manufacturer. METHODS: From 2016 to … Read more
